Manager, Global UDI

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Job Function:
Data Analytics & Computational Sciences

Job Sub Function:
Multi-Family Data Analytics & Computational Sciences

Job Category:
People Leader

Raritan, New Jersey, United States of America, Ringaskiddy, Cork, Ireland, West Chester, Pennsylvania, United States of America

DePuy Synthes is recruiting for a Manager, Global UDI, located in Raynham, MA and Ringaskiddy, Ireland. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements.

• Raynham, MA (USA) – Requisition Number: 078355
• Loughbeg, Ringaskiddy – Requisition Number: 081281

While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s). Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

The Manager, Global UDI is a key leadership role responsible for ensuring global compliance, governance, and execution of Unique Device Identification (UDI) requirements across DePuy Synthes’ orthopedic portfolio. This role partners closely with Regulatory Affairs, IT, Supply Chain, R&D, and Commercial teams to ensure UDI data integrity, system readiness, and regulatory compliance across global markets. This position offers the opportunity to lead a globally impactful compliance program that directly supports patient safety, product traceability, and regulatory readiness while shaping scalable, future‑ready UDI processes and systems.

• Lead and govern the global UDI program, ensuring compliance with FDA, EU MDR, and other applicable international UDI regulations.
• Own UDI‑related quality processes, procedures, and controls, ensuring alignment with standards.
• Partner with IT and digital teams to ensure UDI system design, validation, data integrity, and ongoing system compliance.
• Provide quality oversight for UDI data management, including master data accuracy, change control, and issue remediation.
• Lead cross‑functional collaboration with Regulatory Affairs, Supply Chain, Manufacturing, R&D, and Commercial teams to ensure end‑to‑end UDI execution.
• Support and participate in regulatory inspections, internal audits, and health authority interactions related to UDI compliance.
• Monitor global regulatory trends and translate new or evolving UDI requirements into scalable business and quality processes.
• Drive continuous improvement initiatives to enhance UDI governance, efficiency, and compliance sustainability.
• Provide coaching and leadership to team members and stakeholders to strengthen UDI and quality capabilities across the organization.

• Education Required:
  
  Bachelor’s degree in Engineering, Life Sciences, Information Systems, or a related field.
• Preferred:
  Master’s degree in a scientific, technical, or business discipline.
• Experience and
  
  Skills Required:
  
  6–8 years of relevant experience in Quality Assurance, Regulatory Compliance, or Technology Quality within a regulated industry (medical devices strongly preferred). Demonstrated experience with UDI regulations…